Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine was found to be sensitising to skin in a GPMT test.

This study on Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine is valid for the evaluation of Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

All substances within the AAI group show the same reactive groups, show similar composition of amide, imidazoline, and some dimer structures of both, with the length of original EA amines used for production as biggest difference. Inherent reactivity and toxicity is not expected to differ much between these substances, aspects which determine sensitization.

All skin sensitisation studies performed on AAI substances all indicate them to be sensitising, Consequently, similar results can be expected for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

The following information is available on sensitising properties of AAI substances:

    TO + DETA                            Sensitising: 40% positive reaction in GPMT, i.d. induction 0.1%

    TO + DETA                            Sensitising: LLNA: EC3: 0.3%.

    C16-18, C18 unsat + TEPA   Sensitising: 100% positive reaction in GPMT, i.d. induction 0.1%

    TO + Poly(Amide)                  Sensitising: 100% positive reaction in GPMT, i.d. induction 0.2%

 

Based on the available data, all substances in the AAI group should be considered sensitising to skin.

Classification according to CLP (ATP 2) skin sensitiser: Cat.1A (LLNA: EC 3 ≤ 2%; GPMT ≥ 30% positive at ≤ 0.1% i.d. induction or ≥ 60% positive at >0.1% i.d. induction)

Migrated from Short description of key information:
Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine was found to be sensitising to skin in a GPMT test.

Respiratory sensitisation

Endpoint conclusion
Additional information:

There is no information on respiratory sensitisation, but AAI products are sensitising to skin.

The likelihood for exposure via inhalation and thus becoming sensitised to AAI, is however very low, based on the high boiling point (> 300 °C) and very low vapour pressure (0.00017 mPa at 25°C for DETA based AAI).


Migrated from Short description of key information:
No data.

Justification for classification or non-classification

Various studies with different AAI indicate that these substances can cause dermal sensitisation and should be classified as dermal sensitiser Cat.1A for CLP (Criteria ATP 2, Commission Regulation 286/2011 of 10 March 2011).

The actual risk of sensitisation is probably low, as AAI are corrosive to skin and consequently exposure will be low due to necessary protetive measures to limit dermal exposure.

Also the likelihood for exposure via inhalation and thus becoming sensitised to AAI, is very low, based on the high boiling point (> 300 °C) and very low vapour pressure (0.00017 mPa at 25°C for DETA based AAI).